Quality Manager
Resume:
V. Cathie Stujenske
**** ********* **, ******, ** 38057
**************@*****.*** 901-***-****
PROFESSIONAL SUMMARY
Quality professional with over 25 years of industry experience. Comprehensive background focusing on quality system management, documentation standardization, quality engineering, continuous improvement and employee training in medical device manufacturing.
Comprehensive knowledge of ISO 13485 and 9001 requirements including practical implementation and management experience. Working knowledge of FDA quality system regulation and cGMP for medical devices.
EMPLOYMENT HISTORY
Matrix Machining Technologies, Inc. Memphis, TN Nov 2015-June 2016
Quality Assurance Manager
• Managed the Quality System to ensure compliance with medical device regulations including
ISO 13485 and FDA 21 CFR 820
• Quality Representative during external regulatory body and customer audits
Developed and improved quality documentation including standard operating procedures, work instructions, validation protocols, and inspection plans
Managed Corrective and Preventive Action system
Interacted with customers, vendors and team members concerning quality related issues
Identified and drove continuous improvement initiatives to enhance customer experience, increase efficiency, and standardize processes
Managed change by gaining employee feedback, informing employees, influencing behavior, driving decisions, and setting company policies
Researched new manufacturing and inspection methodologies
Trained and mentored team members
J&B Precision, Inc. Memphis, April 2012-April 2014 and Nov 2014- Nov 2015
Regulatory Manager
• Managed the Quality System to ensure compliance with medical device regulations including
ISO 13485, FDA 21 CFR 820 and ANVISA RDC16-2013
Developed quality documentation including standard operating procedures, work instructions, validation protocols, and inspection plans
Quality Representative during external regulatory body and customer audits
Managed Corrective and Preventive Action system
Interacted with customers, vendors and team members concerning quality related issues
Identified and drove continuous improvement initiatives to enhance customer experience, increase efficiency, and standardize processes
Managed change by gaining employee feedback, informing employees, influencing behavior, driving decisions, and setting company policies
Researched new manufacturing and inspection methodologies
Developed training system and trained and mentored manufacturing team members
Developed gage calibration system
Zimmer, Inc., Memphis, TN April 2014- Nov 2014 Quality Inspector
Performed inspections of purchased parts, subassemblies or finished company products
• Reworked or rejected subassemblies or finished products as required
• Accurately documented the results of the inspections and testing
• Monitored critical equipment and instrumentation to ensure proper operation and
calibration
Performed review of Device History Records and other documentation for compliance to
established procedures and Good Documentation Practices
Smith + Nephew Inc., Memphis, TN Nov 2008 – Dec 2011
Quality Engineering Associate-Gage Design
Collaborated with Quality Control, Product Development, Manufacturing and Supplier Engineers in planning for quality and resolving quality issues
Attended design and print review meetings to discuss dimensional and geometric tolerance methods
Produced and procured final inspection gauging, holding fixtures and overlays for implants and instruments
Performed GR&R studies to ensure proper, reliable, and repeatable gauging
Maintained and revised associated CAD files in product data management software
Mentored and coached individuals and groups for gauging, tolerancing and modeling principles
Participated in the development of a gauge ordering system, providing management with concepts and detailed reports of work in progress
Interacted with outside facilities and vendors regarding gauging issues
Smith + Nephew Inc., Memphis, TN March 1996 – Nov 2008
Quality Engineering Associate I
Supported Quality, Product Development, Manufacturing and Supplier Engineers with new product launch activities for Reconstructive Instrument Team
Created and revised inspection procedures, quality standards and work instructions
Initiated inspection procedure and print changes utilizing computerized change management system
Performed, reviewed and approved first article inspections
Evaluated non-conforming materials for corrective action, analysis and disposition
Instructed Manufacturing Associates in the use of gauges, inspection techniques and product print interpretation
Drove continuous improvement efforts for Instrument Manufacturing Team.
Facilitated Failure, Mode and Effect (FMEA) meetings
Gathered statistical data and provided reject and scrap analysis reports for manufacturing teams
Promoted to Quality Engineering Associate in 1996
Smith + Nephew Inc., Memphis, TN July 1991 – March 1996
Quality Technician I, II, III
Performed first articles and surface plate layouts utilizing various types of inspection equipment such as coordinate measuring machines and optical measuring systems
Calibrated all types of measuring instruments
Participated in process validation studies
Ensured completion and correctness of shop order paperwork
Promoted to Quality Technician II in 1993 and to Quality Technician III in 1995
QUAKER OATS, Dallas, TX July 1988-July 1991
Laboratory Technician
DANA CORPORATION, Lancaster, TX June 1984- July 1988
Machinist
EDUCATION
Southwest Tennessee Community College, Memphis, TN
A.A.S. Mechanical Engineering Technology, 2014
CERTIFICATIONS
Six Sigma Greenbelt Training – Onsite, Smith + Nephew
Manufacturing Fundamentals-Southwest Tennessee Community College
American Society for Quality - Mechanical Inspector, Quality Technician
and Quality Improvement Associate
Geometric Dimensioning and Tolerancing- Jim Meadows Institute
NX Design and Assemblies- Siemens
Screw Machine Set-Up and Operation –Crump Area Vocational and Technical School
Mager Training (Train the Trainer) – Onsite, Smith + Nephew
SKILLS
ISO / FDA Compliance
Standard Operating Procedure / Work Instruction Creation
Corrective and Preventive Action Management
Continuous System and Process Improvement
Change Management
Auditing
Customer / Vendor Communication
Quality Reporting
Equipment Validation - IQ/OQ/PQ
Statistical Process Control
Product Inspection / Blueprint Interpretation / Gauge Calibration / Metrology
Machining
Gauge Development
Geometric Dimensioning and Tolerancing
Mentoring / Coaching / Training
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